Treatment of Breast Lift/Reduction Scars

Sciton

Status: Withdrawn

Conditions: Scars

Treatments: Other: Non-treatment side (Control); Device: 2940nm and BBL treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05123508

SCARCIP001

Details and patient eligibility

About

Laser and light treatment for surgical scars following breast lifts/reductions

Full description

The purpose of the study is to demonstrate effectiveness of laser and light therapy for the treatment of surgical scars following breast lifts/reductions.

Sex: Female

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy female subjects between 25 to 60 years of age inclusive
2. Fitzpatrick skin type I-IV
3. Subjects with post-surgical breast lift/reduction scar
4. A maximum of 8-10 weeks since surgery
5. Healed surgery wound in the treatment area
6. Willing to have photographs taken of the treatment area
7. Can read, understand and sign informed consent form (English only)
8. Has indicated willingness to participate in the study by signing an informed consent form
9. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion criteria

1. Fitzpatrick skin type V-VI
2. Breast reconstruction with radiation treatment
3. Is pregnant and/or lactating
4. Has tattoos, dysplastic nevi in the treatment area
5. History or current photosensitivity
6. History or current use of medication with photosensitizing properties within past 6 months
7. History or current of chronic reoccurring skin disease or disorder affecting treatment area
8. History or current cancer of any type
9. Has hormonal disorder
10. Has signs of actinic bronzing
11. Has open lacerations, and abrasions on the treatment area
12. History of keloid formation, or hypertrophic scar formation, or poor wound healing
13. History of bleeding disorder, or is currently taking anticoagulation medications
14. Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
15. Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
16. The investigator feels that for any reason the subject is not eligible to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

2940nm laser and BBL treatment

Treatment:

Device: 2940nm and BBL treatment

Control Arm

Experimental group

Description:

One side of the treatment area will act as a control. No treatment on the control side.

Treatment:

Other: Non-treatment side (Control)